Reporting Obligations for Medical Device Manufacturers
Nov 13, 2024
Market Access
Tailored Market Access Advice
What We Do
Our Market Access team helps you understand your product compliance obligations by transforming regulations into actionable knowledge. Our team of librarians and legal/regulatory experts ensure you have the right information to unlock your product’s global revenue potential.
Our Market Access Services
Our Market Access team addresses the ‘letter of the law’ for both regulations and mandatory standards worldwide. We help create actionable plans for your unique product compliance needs across almost any country, product or policy area.
product snapshots
- Introduction and general understanding of legislative requirements for specific products & countries
- Include all applicable regulations and mandatory standards, with citations, links and high-level summaries
- Graphical tables allowing you to jump quickly to your obligations, whether they be labeling, chemicals, safety, etc
Regulatory COMPLIANCE reviews
- Designed to answer your unique compliance questions, whether high-level summaries, detailed analyses, FAQs, etc.
Focus on the landscape affecting:
- Any country of the world
- Nearly any product you can purchase for yourself or your home, such as batteries, packaging, textiles, cosmetics and toys; and/ or
- Legislative hot topics, including BREXIT, REACH, right-to-repair, EPR, recalls, etc.
Test protocols
- Checklists of testing and certification requirements for specific products & countries.
- Include regulations and standards addressing labeling, chemicals, packaging, safety, quality and performance.
- Replied upon by manufacturers, retailers and their testing partners in demonstrating compliance globally.
Activate Your Global Business with Compliance & Risks
- Maintain and Secure Global Compliance
- Comply With International Requirements
- Shorter Time to Market
Testimonials
Sending non-compliant products to our customers could result in costly order changes and delays at custom borders.
Barb Wert
Sr. Regulatory Compliance Specialist, Foxguard
Testimonials
I need to monitor changes to environment and safety regulations applicable to our products throughout the world.
Sebastien Marcel
Global Environment Manager, Markem-Imaje
Testimonials
We need to be able to readily identify emerging product-related regulatory issues around the world, and to manage them in an efficient manner.
Ian Barford
Senior HSE Manager, Kodak
Ask Our Compliance Experts
Direct access to our Global Regulatory Compliance Team, and Knowledge Partner Network.
Our global team of SME’s, with expertise across a diverse range of products, geographies, and policy areas, collaborate with our knowledge partners to monitor, research and report on all things compliance related
